Congenital Heart DiseaseNCT05332860
Extubation Times in Postoperative Congenital Cardiovascular Surgeries
An observational study of Congenital Heart Disease, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background: Anesthesia management in pediatric cardiac surgeries focuses on reducing morbidity and mortality, early mobilization and discharge, using health resources sparingly and increasing the quality of life of patients. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Congenital Cardiovascular Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 15 Feb 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 72 patients
Who may be able to join
- elective or emergency patients
- aged 0-18 who are scheduled for congenital heart surgery
Who cannot join
- -in patients who died during the operation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Training and Research Hospital
Bursa, 16600
About this study
Official title: Evaluation of Factors Affecting Extubation Times in Postoperative Congenital Cardiovascular Surgeries: A Randomized Prospective Study
Background: Anesthesia management in pediatric cardiac surgeries focuses on reducing morbidity and mortality, early mobilization and discharge, using health resources sparingly and increasing the quality of life of patients. The duration of postoperative mechanical ventilation is one of the most important factors affecting the process after pediatric cardiac surgery. Besides the view that postoperative mechanical ventilation is safe, there are opposing views that it causes an increase in complications; It caused disagreements about extubation times. In our study, we aimed to investigate the factors affecting extubation times after pediatric cardiac surgery.
Methods: 72 ASA≥III pediatric patients undergoing cardiac surgery with cardiopulmonary bypass were included in our study. The patients were divided into 3 groups according to their extubation time. Those that were extubated in the operating room (OR) or in 6 hours after surgery (Immediate Extubation or IE), those that were extubated within 6-48 hours of admission to the ICU (Early Extubation or EE) and those that were extubated sometime after 48 hours or not extubated (Delayed Extubation or DE). Many variables of preoperative, peroperative and postoperative periods were recorded to see which factors correlated with extubation times.
Read the detailed description
Children with critical congenital heart disease may need surgical or interventional procedures at some point in their lives.In pediatric cardiac anesthesia, it is important to reduce the need for postoperative mechanical ventilation in order to minimize morbidity, provide optimal vital functions, and reduce unnecessary use of health resources. Researchers aimed to examine the relationships of perioperative and postoperative hemodynamics, laboratory, oxygenation parameters and demographic data with extubation times in pediatric cardiac surgery cases taken in the hospital.
- Conditions
- Congenital Heart Disease
- Being tested
- Congenital Cardiovascular Surgery
- Keywords
- Congenital heart disease, perioperative management, pediatric cardiac surgery, extubation
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Congenital Cardiovascular SurgeryProcedure or surgery
Relationship between perioperative and postoperative hemodynamics, laboratory, oxygenation parameters and demographic data with extubation times in pediatric cardiac surgery cases taken in our hospital.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Extubation or IE | patients were extubated in the operating room (OR) or in 6 hours after surgery Receives: Procedure: Congenital Cardiovascular Surgery | |
| Early Extubation or EE | patients were extubated within 6-48 hours of admission to the ICU Receives: Procedure: Congenital Cardiovascular Surgery | |
| Delayed Extubation or DE | patients were extubated sometime after 48 hours or not extubated Receives: Procedure: Congenital Cardiovascular Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
extubation times
postoperative mechanical ventilation times
Measured: 10 days after surgery
Secondary outcomes (1)
mortality
mortality rates of groups
Measured: on 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 May 2020
- Primary completion31 Dec 2020
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tugba Onur, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Tuğba T Onur, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research HospitalÜmran Ü Karaca, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalAnıl A Onur, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalMesut M Engin, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalAsiye A Demirel, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalHalil Erkan HE Sayan, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalŞeyda Efsun ŞE Özgünay, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalNermin N Kılıçarslan, MD, Study chair, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332860
- Sponsor's protocol ID
- Bursa Education Hospital
- Status last verified
- Mar 2023
- First submitted
- 22 Mar 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Factors Affecting Extubation Times in Postoperative Congenital Cardiovascular Surgeries: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT05332860
- Acronym / sponsor ID
- Bursa Education Hospital
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, perioperative management, pediatric cardiac surgery, extubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Anesthesia management in pediatric cardiac surgeries focuses on reducing morbidity and mortality, early mobilization and discharge, using health resources sparingly and increasing the quality of life of patients. The duration of postoperative mechanical ventilation is one of the most important factors affecting the process after pediatric cardiac surgery. Besides the view that postoperative mechanical ventilation is safe, there are opposing views that it causes an increase in complications; It caused disagreements about extubation times. In our study, we aimed to investigate the factors affecting extubation times after pediatric cardiac surgery.
Methods: 72 ASA≥III pediatric patients undergoing cardiac surgery with cardiopulmonary bypass were included in our study. The patients were divided into 3 groups according to their extubation time. Those that were extubated in the operating room (OR) or in 6 hours after surgery (Immediate Extubation or IE), those that were extubated within 6-48 hours of admission to the ICU (Early Extubation or EE) and those that were extubated sometime after 48 hours or not extubated (Delayed Extubation or DE). Many variables of preoperative, peroperative and postoperative periods were recorded to see which factors correlated with extubation times.
Detailed description
Children with critical congenital heart disease may need surgical or interventional procedures at some point in their lives.In pediatric cardiac anesthesia, it is important to reduce the need for postoperative mechanical ventilation in order to minimize morbidity, provide optimal vital functions, and reduce unnecessary use of health resources. Researchers aimed to examine the relationships of perioperative and postoperative hemodynamics, laboratory, oxygenation parameters and demographic data with extubation times in pediatric cardiac surgery cases taken in the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate Extubation or IE | – | Procedure: Congenital Cardiovascular Surgerypatients were extubated in the operating room (OR) or in 6 hours after surgery |
| Early Extubation or EE | – | Procedure: Congenital Cardiovascular Surgerypatients were extubated within 6-48 hours of admission to the ICU |
| Delayed Extubation or DE | – | Procedure: Congenital Cardiovascular Surgerypatients were extubated sometime after 48 hours or not extubated |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 72 patients
Key inclusion criteria (2 listed)
- elective or emergency patients
- aged 0-18 who are scheduled for congenital heart surgery
Key exclusion criteria (1 listed)
- -in patients who died during the operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Congenital Cardiovascular SurgeryRelationship between perioperative and postoperative hemodynamics, laboratory, oxygenation parameters and demographic data with extubation times in pediatric cardiac surgery cases taken in our hospital. | Procedure or surgery | Delayed Extubation or DE, Early Extubation or EE, Immediate Extubation or IE |
Primary outcome
extubation times
Time frame: 10 days after surgery
postoperative mechanical ventilation times
1 secondary outcome
mortality
Time frame: on 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuğba T Onur, MD principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
Ümran Ü Karaca, MD study chair
Bursa Yuksek Ihtisas Training and Research Hospital
Anıl A Onur, MD study chair
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
extubation times (time frame: 10 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.